Edgewise should be bought on weakness as ARCH not likely FDA focus, says Truist

Truist notes that Edgewise Therapeutics (EWTX) is down about 6%, presumably due to FDA citing misconduct of trials at Dr. Han Phan’s clinical trial site in Atlanta. The firm has reasons to believe that Edgewise’s ARCH study is not the study in question, highlighting that the letter states “objectionable conditions” at the clinical trial site between April 1 to April 5 in a study that enrolled 42 participants and noting that the ARCH study concluded in March and enrolled 12 patients. The firm suspects the FDA issued warning letters to both the clinical trial site and principal investigator and the sponsor on the same day, which may imply Applied Therapeutics (APLT) is the sponsor in question. The firm, which recommends investors buy on weakness, reiterates a Buy rating and $50 price target on Edgewise shares.